An observational study in Breast Cancer, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-07-07.
Sponsored by Seoul National University Hospital · Observational
The purpose of this study is:
To validate the efficacy of multiparametric MRI, FDG-PET, RGD-PET, and PET-MR fusion imaging in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced breast cancer patients.
To identify the optimal combination parameters of MR spectroscopy, diffusion-weighted MRI, dynamic contrast-enhanced MRI, FDG-PET, and RGD-PET in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced breast cancer patients.
To compare the performances of dynamic contrast-enhanced MRI using parametric response map analysis versus those of pharmacokinetic parameters (Ktrans, kep, or Ve) in the early prediction of pathological responsiveness to neoadjuvant chemotherapy in breast cancer patients
Enrolled women with breast cancers who had received an anthracycline-taxane regimen and subsequent surgery were prospectively enrolled. DCE-MRI and FDG-PET scan were performed before and after the 1st cycle of chemotherapy. MR imaging parameters and SUV on PET scan within a tumor were analyzed. Clinicopathologic (age, clinical tumor stage, hormonal receptor status, and surgery type) and imaging parameters were compared according to the pathological response.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 57 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Breast cancer patients who are candidates for neoadjuvant chemotherapy, pre-treatment MRI and PET scan, post-treatment MRI and PET scan for evaluation of chemotherapy response monitoring and residual disease
Exclusion Criteria:
Patholocial Response to Chemotherapy
Pathological complete response (pCR) or non-pCR
Time frame: Post-operation
Tumor Size
Maximal tumor diameter measured on magnetic resonance imaging
Time frame: baseline, completion of 1st cycle of chemotherapy
Tumor Volume
Tumor volume measured on 3-dimensional magnetic resonance imaging
Time frame: Baseline, post-1st chemotherapy
Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI)
Parametric response map analysis using a software calculates the interval change of signal intensity based on a voxel-to-voxel comparison between measurements at baseline and after the first cycle of chemotherapy. PRMSI+ indicates proportions of voxels within a tumor with increased signal intensity. PRMSI- indicates proportions of voxels within a tumor with decreased signal intensity. PRMSI0 indicates proportions of voxels within a tumor with unchanged signal intensity.
Time frame: Baseline, post-1st chemotherapy
Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans)
Time frame: Baseline, post-1st chemotherapy
Rate Constant of the Escape of the Contrast Agent From the Extracellular Extravascular Space Into the Plasma Compartment (Kep)
Time frame: Baseline, post-1st chemotherapy
Extracellular Extravascular Space Per Unit Volume of Tissue (Ve)
Time frame: Baseline, post-1st chemotherapy
Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy
Single voxel 1H-magnetic resonance spectroscopy quantifies the amount of total choline-containing compounds of a tumor, which indicates cellular proliferation and malignant transformation.
Time frame: Baseline, post-1st chemotherapy
Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography
Time frame: Baseline, post-1st chemotherapy
| Milestone | Pathologic Complete Responders (pCR) | Non-pCR |
|---|---|---|
| Started | 6 | 42 |
| Completed | 6 | 42 |
| Not completed | 0 | 0 |
Pathological complete response (pCR) or non-pCR
| participants | Pathologic Response to Chemotherapy |
|---|---|
| Pathologic completer Responders (pCR) | 6 |
| Non-pCR | 42 |
Maximal tumor diameter measured on magnetic resonance imaging
| cm | Pathologic Complete Responders (pCR) | Non-pCR |
|---|---|---|
| Baseline tumor size | 4.9 ± 1.8 | 5.0 ± 2.0 |
| Post-1st chemotherapy tumor size | 4.2 ± 1.8 | 4.5 ± 1.8 |
Tumor volume measured on 3-dimensional magnetic resonance imaging
| cm3 | Pathologic Complete Responders (pCR) | Non-pCR |
|---|---|---|
| Baseline | 22.0 ± 18.7 | 38.9 ± 89.8 |
| Post-1st chemotherapy | 11.0 ± 13.2 | 26.4 ± 44.4 |
Parametric response map analysis using a software calculates the interval change of signal intensity based on a voxel-to-voxel comparison between measurements at baseline and after the first cycle of chemotherapy. PRMSI+ indicates proportions of voxels within a tumor with increased signal intensity. PRMSI- indicates proportions of voxels within a tumor with decreased signal intensity. PRMSI0 indicates proportions of voxels within a tumor with unchanged signal intensity.
| % of voxels | Pathologic Complete Responders (pCR) | Non-pCR |
|---|---|---|
| PRMSI+ | 14.0 ± 6.5 | 40.7 ± 27.2 |
| PRMSI- | 83.4 ± 7.6 | 56.4 ± 27.8 |
| PRMSI0 | 2.7 ± 1.4 | 2.9 ± 1.5 |
| min-1 | Pathologic Complete Responders (pCR) | Non-pCR |
|---|---|---|
| Baseline Ktrans | 0.263 ± 0.044 | 0.254 ± 0.080 |
| Post-1st chemotherapy Ktrans | 0.224 ± 0.076 | 0.234 ± 0.068 |
| min-1 | Pathologic Complete Responders (pCR) | Non-pCR |
|---|---|---|
| Baseline | 0.616 ± 0.262 | 0.787 ± 0.729 |
| Post-1st chemotherapy | 0.992 ± 0.917 | 0.616 ± 0.298 |
| unitless | Pathologic Complete Responders (pCR) | Non-pCR |
|---|---|---|
| Baseline | 0.563 ± 0.129 | 0.550 ± 0.146 |
| Post-1st chemotherapy | 0.467 ± 0.151 | 0.557 ± 0.136 |
Single voxel 1H-magnetic resonance spectroscopy quantifies the amount of total choline-containing compounds of a tumor, which indicates cellular proliferation and malignant transformation.
| unitless | Pathologic Complete Responders (pCR) | Non-pCR |
|---|---|---|
| Baseline | 15.0 ± 8.4 | 13.5 ± 11.5 |
| Post-1st chemotherapy | 3.4 ± 2.8 | 7.8 ± 6.3 |
| unitless | Pathologic Complete Responders (pCR) | Non-pCR |
|---|---|---|
| Baseline | 18.9 ± 12.1 | 10.7 ± 5.6 |
| Post-1st chemotherapy | 9.7 ± 10.7 | 7.6 ± 4.4 |
Collected over Baseline, post-1st chemotherapy, preoperative timing. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pathologic Complete Responders (pCR) | — | 0/6 (0%) | 0/6 (0%) |
| Non-pCR | — | 0/42 (0%) | 0/42 (0%) |
| Age, Customized(participants) | Pathologic Complete Responders (pCR) | Non-pCR | Total |
|---|---|---|---|
| 40 years old or less | 2 | 9 | 11 |
| more than 40 years old | 4 | 33 | 37 |
| Sex: Female, Male(Participants) | Pathologic Complete Responders (pCR) | Non-pCR | Total |
|---|---|---|---|
| Female | 6 | 42 | 48 |
| Male | 0 | 0 | 0 |
| Clinical stage (American Joint Committee on Cancer 7th edition)(participants) | Pathologic Complete Responders (pCR) | Non-pCR | Total |
|---|---|---|---|
| Stage II | 2 | 8 | 10 |
| Stage III | 4 | 34 | 38 |
| Estrogen receptor(participants) | Pathologic Complete Responders (pCR) | Non-pCR | Total |
|---|---|---|---|
| Negative | 5 | 16 | 21 |
| Positive | 1 | 26 | 27 |
| Progesterone receptor(participants) | Pathologic Complete Responders (pCR) | Non-pCR | Total |
|---|---|---|---|
| Negative | 5 | 31 | 36 |
| Positive | 1 | 11 | 12 |
| HER2(participants) | Pathologic Complete Responders (pCR) | Non-pCR | Total |
|---|---|---|---|
| Negative | 5 | 32 | 37 |
| Positive | 1 | 10 | 11 |
| Ki-67 (Cellular marker for proliferation)(participants) | Pathologic Complete Responders (pCR) | Non-pCR | Total |
|---|---|---|---|
| 14% or less (low proliferation) | 2 | 28 | 30 |
| more than 14% (high proliferation) | 4 | 14 | 18 |
| Immunohistochemical subtype(participants) | Pathologic Complete Responders (pCR) | Non-pCR | Total |
|---|---|---|---|
| Hormone receptor positive | 1 | 26 | 27 |
| Triple negative | 4 | 10 | 14 |
| HER2-positive | 1 | 6 | 7 |
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital